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Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms

Clinical cancer research, 2016-04, Vol.22 (7), p.1553-1558

2016

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Regulatory considerations on endpoints in ovarian cancer drug development

Cancer, 2017-07, Vol.123 (14), p.2604-2608

2017

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Decoding kinase-adverse event associations for small molecule kinase inhibitors

Nature communications, 2022-07, Vol.13 (1), p.4349-4349, Article 4349

2022

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From big data to smart data: FDA's INFORMED initiative

Nature reviews. Drug discovery, 2017-02, Vol.16 (5), p.306-306

2017

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An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

Clinical cancer research, 2017-03, Vol.23 (6), p.1368-1372

2017

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Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle

Clinical cancer research, 2016-06, Vol.22 (11), p.2613-2617

2016

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US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments

Journal of clinical oncology, 2018-04, Vol.36 (12), p.1225-1231

2018

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Dose dependence of treatment-related adverse events for immune checkpoint inhibitor therapies: a model-based meta-analysis

Oncoimmunology, 2020-01, Vol.9 (1), p.1748982

2020

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Clinical Development of Cancer Drugs in Combination With External Beam Radiation Therapy: US Food and Drug Administration Perspective

International journal of radiation oncology, biology, physics, 2017-05, Vol.98 (1), p.5-7

2017

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L‐asparaginase inhibits invasive and angiogenic activity and induces autophagy in ovarian cancer

Journal of cellular and molecular medicine, 2012-10, Vol.16 (10), p.2369-2378

2012

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FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the U.S. Food and Drug Administration

Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.10009-10009

2017

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Regulatory watch: From big data to smart data: FDA's INFORMED initiative

Nature reviews. Drug discovery, 2017-05, Vol.16 (5), p.306-306

2017

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Diagnosing leptomeningeal carcinomatosis with negative CSF cytology in advanced prostate cancer

Journal of clinical oncology, 2008-07, Vol.26 (19), p.3281-3284

2008

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U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer

Clinical cancer research, 2017-08, Vol.23 (16), p.4534-4539

2017

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FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy

Clinical cancer research, 2015-10, Vol.21 (19), p.4257-4261

2015

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21st Century Cardio-Oncology

JACC. Basic to translational science, 2016-08, Vol.1 (5), p.386-398

2016

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FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Clinical cancer research, 2015-11, Vol.21 (21), p.4760-4766

2015

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FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti‐Angiogenic Therapy and Exploratory Predictive Biomarker Analysis

The oncologist (Dayton, Ohio), 2017-03, Vol.22 (3), p.311-317

2017

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FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer

Clinical cancer research, 2017-12, Vol.23 (23), p.7165-7170

2017

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FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy

The oncologist (Dayton, Ohio), 2017-06, Vol.22 (6), p.743-749

2017

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FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Clinical cancer research, 2016-10, Vol.22 (20), p.4968-4972

2016

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Challenges and Opportunities in Dose Finding in Oncology and Immuno‐oncology

Clinical and translational science, 2018-07, Vol.11 (4), p.345-351

2018

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Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA

Nature reviews. Drug discovery, 2016-10, Vol.15 (10), p.670

2016

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Enrollment of older adults on oncology trials: An FDA perspective

Journal of geriatric oncology, 2017-05, Vol.8 (3), p.149-150

2017

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FDA analysis of patients with baseline autoimmune diseases treated with PD-1/PD-L1 immunotherapy agents

Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.3018-3018

2017

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Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms

Regulatory considerations on endpoints in ovarian cancer drug development

Decoding kinase-adverse event associations for small molecule kinase inhibitors

From big data to smart data: FDA's INFORMED initiative

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle

US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments

Dose dependence of treatment-related adverse events for immune checkpoint inhibitor therapies: a model-based meta-analysis

Clinical Development of Cancer Drugs in Combination With External Beam Radiation Therapy: US Food and Drug Administration Perspective

L‐asparaginase inhibits invasive and angiogenic activity and induces autophagy in ovarian cancer

FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the U.S. Food and Drug Administration

Regulatory watch: From big data to smart data: FDA's INFORMED initiative

Diagnosing leptomeningeal carcinomatosis with negative CSF cytology in advanced prostate cancer

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer

FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy

21st Century Cardio-Oncology

FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti‐Angiogenic Therapy and Exploratory Predictive Biomarker Analysis

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer

FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy

FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Challenges and Opportunities in Dose Finding in Oncology and Immuno‐oncology

Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA

Enrollment of older adults on oncology trials: An FDA perspective

FDA analysis of patients with baseline autoimmune diseases treated with PD-1/PD-L1 immunotherapy agents

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